FDA product code NVJ: Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
NVJ is the FDA product code for applicator, transurethral, radio frequency, for stress urinary incontinence in women. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NVJ. The average 510(k) review took 134 days (median 134). FDA has posted 1 recall for NVJ devices.
Definition
Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NVJ clearance
Top NVJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Novasys Medical, Inc. | 1 | 2004-12-21 |
Most recent NVJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042132 | Novasys Medical, Inc. | NOVASYS TRANSURETHRAL RF SYSTEM | 2004-12-21 | 134 |
Recalls for NVJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-07-27.
Frequently asked questions
What is FDA product code NVJ?
NVJ is the FDA product code for applicator, transurethral, radio frequency, for stress urinary incontinence in women. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is NVJ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVJ?
Across 1 cleared submissions the average was 134 days from receipt to decision (median 134).
Which companies have the most NVJ clearances?
Novasys Medical, Inc. (1).
Have NVJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-07-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NVJ
- Run a recall and safety report across every NVJ manufacturer
- Watch product code NVJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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